Tip protector for a safety catheter

ABSTRACT

A safety catheter includes a catheter hub, a needle cannula having a tip, and a tip protector. The tip protector includes an outer member and an inner member therein. The outer member has a projection releasably engaging the catheter hub. The inner member has a pair of arms extending to free ends from a base. The inner member is axially shiftable relative to the outer member between a first position wherein the needle tip is distal of the tip protector and the free ends of the arms are spread apart such that the distal tip is not shielded, and a second position wherein the tip is within the inner and outer members and the free ends of the arms are brought into close proximity such that the distal tip is shielded. The inner member is entirely received within the outer member in both the fort and the second positions thereof.

RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.12/792,290 filed Jun. 2, 2010, the disclosure of which is incorporatedherein by reference in its entirety.

TECHNICAL FIELD

The present invention relates to safety catheters and, moreparticularly, to tip protectors to shield the sharp tip of the needlecannula used with the catheter.

BACKGROUND

Safety catheters are widely used and typically include a catheter hubwith a catheter tube extending distally thereof to be placedintravenously, a needle hub or support with a needle cannula extendingdistally thereof to a sharp distal tip and extending through thecatheter tube to expose the sharp tip in order to facilitate intravenousinsertion of the catheter tube, and a tip protector through which atleast a portion of the needle shaft passes and adapted to enclose orotherwise shield the tip of the needle cannula after it has beenwithdrawn from the catheter tube and into the tip protector.

One form of tip protector involves a clip that fits within the catheterhub. Such clips are readily recognized in that they are thin webs ofmetal or the like which are bent or otherwise formed to have a back walland one or more distally extending walls, all generally of the samethickness. In a ready state of the clip, the needle shaft of the needlecannula passes through an aperture in the back wall of the clip andagainst the distally extending arm of the clip, and between the armswhere there are two of them, to pass into the catheter tube in order toexpose the sharp tip. The needle cannula may be pulled proximally so asto bring the sharp tip within the clip proximal of the distal end wallsof the arm(s), whereupon the arms close down to block distalre-emergence of the sharp tip. Also, a protuberance or other feature ofthe needle shaft near the sharp tip is sized not to readily pass throughthe back wall aperture, such that the protuberance engages against theback wall. The sharp tip is thus considered protected by the clip, whichmay be thought of as the locked or fired position. Any further proximalmovement of the needle cannula will pull the clip out from the catheterhub.

Portions of the clip may be urged radially outwardly into engagementwith an internal feature of the catheter hub so as to secure the clipwithin the hub. In one form, the presence of the needle against an arm(and between two of them, if present) urges an aspect of the arm(s)radially outwardly into engagement with a rib or groove of the catheterhub. In that form of clip, when the needle tip is pulled into the clipin the fired position, closing down of the arms also causes the armaspect to move radially inwardly and away from engagement with thecatheter hub, thereby releasing the clip for easy removal from thecatheter hub. That form of design may be thought of as a passive tipprotector, in that the user need do little more to remove the clip fromthe catheter hub than pull the sharp tip into the clip. In another form,an aspect of the clip remains urged into engagement with the catheterhub even in the fired position, such that removal thereof requiresapplication of a force to overcome the engagement, with the force beingapplied by tugging the needle cannula proximally to overcome the force.The latter type of design may be thought of as an active tip protectorin that the user must apply the added tugging force to overcome the holdof the clip to the catheter hub in order to remove the clip.

Clips have a disadvantage in that they tend to scrape along the needleshaft as the needle cannula is pulled proximally from the ready positionto the fired position. That scraping is objectionable and can beparticularly problematic in the passive tip protector due to the forcesinvolved in the needle shaft urging the arms radially outwardly intoengagement with catheter hub. In the active tip protector, the forcesinvolved between the clip arm(s) and the needle shaft can be lessened,but at the expense, in part, of requiring higher removal forces, whichcan be objectionable.

A couple of recent proposals have sought to separate the catheter hubengagement function of the clip from the clip protective function so asto obtain the benefit of easy removal provided by passive tip protectorswith the reduced forces on the needle shaft provided by active tipprotectors. Those proposals involve an outer member about the clip, withthe outer member having an engagement portion held radially outwardlyinto engagement with the catheter hub feature by the clip in the readyposition. In those proposals, a portion of the clip is adjacent theouter member engagement portion so as to limit the ability thereof tomove radially inwardly and release engagement with the catheter hub.When the needle tip is brought into the clip to place the clip in thefired position, further proximal movement of the needle cannula pullsthe clip proximally relative to the outer member to misalign the clipportion from the outer member engagement portion into a release positionsuch that the engagement portion can move radially inwardly and out ofengagement with the catheter hub. These proposals thus involve a clip asan inner member and an outer member thereabout, with the two beingaxially shiftable from the ready and fired positions to the releaseposition.

Those proposals seemingly provide the benefits of reduced needle shaftand clip arm forces of the active tip protectors, with the ease ofremoval of the passive tip protectors. But they still have drawbacks andcan benefit from improvements.

SUMMARY

The present invention provides safety catheters with tip protectorsutilizing axially shiftable members, but which overcome drawbacks ofprior proposals and improve thereon. To that end, and in accordance witha feature of the present invention, it is determined that the priorproposals required that the clip defining the inner member be partiallywithin the axial extent of the outer member and partially exposed so asto be at least partially within the axial extent of the catheter hubdistal of the outer member. In one aspect of the present invention, thetip protector has an outer member, with the engagement portion definedby one or more flexible tabs thereof which can extend radially outboardof the body of the outer member to engage the catheter hub and can moveradially inwardly to release therefrom, and the inner member is sizedand positioned to be completely within the axial extent of the outermember. The inner member has a portion to impede radially inwardmovement of the flexible tab when the inner member portion is disposedaxially adjacent the flexible tab. The inner member is axially shiftablerelative to the outer member between a first position wherein the distaltip, which may be a sharp tip or a blunt tip, extends distally of thetip protector and the inner member portion is disposed axially adjacentthe flexible tabs so as to impede release of the outer member from thecatheter hub, and a second position wherein the distal tip is within theouter member and the inner member is moved such that the inner memberportion is no longer disposed axially adjacent the flexible tab suchthat the inner member no longer impedes release of the outer member fromthe catheter hub. In all positions of the inner and outer members inuse, the inner member is retained completely within the axial extent ofthe outer member. The outer member may be in the form of a cylindricalbody member, with the inner member being a multi-thickness member thatdefines an outer, cylindrical periphery conforming to the interior shapeof the outer member cylinder.

In accordance with another feature of the present invention, it isdetermined that the outer member of the prior proposals were generallyplastic or other elastomeric material, and thus are relatively thick.That thickness consumes some of the valuable cross-dimensional space ofthe catheter hub interior, and so limits the cross-dimension of theclip. In a further aspect of the invention, the outer member is athin-walled metal body, such that there is more interior space availablefor the inner member. Further, in accordance with this further aspect ofthe invention, the inner member is advantageously not a clip, but isinstead a multi-thickness plastic molded component, which can thus takeadvantage of the extra interior space left open by the use of the metalbody outer member. The outer member may be in the form of a cylindricalbody member, with the inner member defining an outer, cylindricalperiphery conforming to the interior shape of the outer member cylinder.

In a particularly advantageous form of the inner plastic member, theproximal end thereof is provided with a metal washer to define the backwall aperture. As a consequence, a protuberance of the needle cannulaengages with metal rather than plastic, so as to reduce the risk ofdeformation of the plastic which might allow the protuberance thereat topass through the back end of the inner member.

In accordance with a still further feature of the present invention, thearms of the inner member may define on confronting faces thereofrespective portions of a tapered bore, such that as the inner member ismoved into the release position, and the arms come together, the taperedbore portions cooperate to define a tapered bore, or the effect of one,which narrows down to a distal portion of a passageway that is less thanthe diameter of the needle cannula, so as to limit distal re-emergenceof the sharp tip therefrom. In a particularly advantageous form, theinner member is a multi-thickness plastic molded component whichfacilitates ready formation of the tapered bore portions in each armthereof. In some forms, notably where small diameter needle cannulae areinvolved, the arms may also be provided with confronting ribs distal ofthe needle tip that mate together in the fired and/or released positionsto further reduce the likelihood of distal re-emergence of the needletip.

In accordance with yet another feature of the present invention, clipsare generally prone to what is known as side-out by which the needlecannula may re-orient in the fired position so as to project the sharptip out from between the arms along the side(s) of the clip. Some clipshave been designed with free-standing wings in an effort to providesidewalls to the clip. In accordance with a yet further aspect of thepresent invention, the confronting face of the arms may be provided withone or more sidebites, comprising at least one axially extendingprojection on the face of one of the arms, and an axially extendingnotch in the face of the other arm. A sidebite interengages when theinner member is in the fired (and release) position, so as to reduce thelikelihood of lateral offset of the arms and/or side-out. In aparticularly advantageous form, the inner member is a multi-thicknessplastic member so as to facilitate formation of the sidebite(s).

In accordance with still another feature of the present invention, it isdetermined that the inner member can be designed with the arms beingnormally urged radially outwardly, so as to significantly reduce, if notwholly, eliminate the forces between the needle shaft and the innermember during movement of the needle cannula from the ready state to thefired state. In embodiments having the confronting ribs, the radiallyoutward bias, in combination with the radial extent of the ribs,positions the ribs such that they do not touch the needle shaft in theready position, thus further reducing the risk of forces between theneedle shaft and the inner member.

By virtue of the foregoing, individually and in combination, there arethus provided safety catheters with tip protectors utilizing axiallyshiftable members, but which overcome drawbacks and improve on priorproposals of such tip protectors. These and other objects and advantagesof the present invention shall be made apparent from the accompanyingdrawings and description thereof.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate embodiments of the invention and,together with the general description given above and the detaileddescription of the embodiments given below, serve to explain theprinciples of the invention.

FIG. 1 is a disassembled perspective view of a safety catheter inaccordance with one embodiment of the invention;

FIG. 2 is an assembled perspective view of the safety catheter shown inFIG. 1, but without the protective sheath;

FIG. 3 is a perspective view of the inner member of the tip protector inaccordance with one embodiment of the invention;

FIG. 4 is a cross-sectional view of the inner member shown in FIG. 3taken generally along line 4-4 in FIG. 3;

FIG. 5 is a cross-sectional view of the inner member of the tipprotector taken generally along line 5-5 in FIG. 3;

FIG. 6 is a perspective view of the outer member of the tip protector inaccordance with one embodiment of the invention;

FIG. 7 is a cross-sectional view of the outer member shown in FIG. 6taken generally along line 7-7 in FIG. 6;

FIG. 8 is a cross-sectional view of the outer member shown in FIG. 6taken generally along line 8-8 in FIG. 6;

FIG. 9 is a partial perspective view of the needle assembly inaccordance with one embodiment of the invention;

FIG. 10 is a partial cross-sectional view of the needle assembly shownin FIG. 9 taken generally along line 10-10 in FIG. 9;

FIG. 11 is a partial perspective view of the needle cannula showing anengaging feature in accordance with one embodiment of the invention;

FIG. 12 is a cross-sectional view of the needle cannula shown in FIG. 11taken generally along line 12-12 in FIG. 11;

FIG. 13 is a partial perspective view of the catheter assembly inaccordance with one embodiment of the invention;

FIG. 14 is a partial cross-sectional view of the catheter assembly shownin FIG. 13 taken generally along line 14-14 in FIG. 13;

FIG. 15 is an enlarged view of the encircled portion shown in FIG. 14;

FIG. 16A is a partial cross-sectional view of the safety catheter in theready position, wherein the inner member is in a first position relativeto the outer member;

FIG. 16B is another partial cross-sectional view of the safety catheterin the ready position and 90° offset from the view shown in FIG. 16A;

FIG. 17A is a partial cross-sectional view of the safety catheter withthe distal tip of the needle cannula disposed in the tip protector;

FIG. 17B is another partial cross-sectional view of the safety catheterwith the distal tip of the needle cannula disposed in the tip protectorand 90° offset from the view shown in FIG. 17A;

FIG. 18A is a partial cross-sectional view of the safety catheter in theprotected position, wherein the inner member is in a second positionrelative to the outer member;

FIG. 18B is another partial cross-sectional view of the safety catheterin the protected position and 90° offset from the view shown in FIG.18A;

FIG. 19 is a partial perspective view of the needle assembly with thedistal tip of the needle cannula shielded by the tip protector;

FIG. 20 is a perspective view of an inner member of the tip protector inan alternative embodiment in accordance with the invention;

FIG. 21 is a perspective view of an inner member of the tip protector ina further alternative embodiment in accordance with the invention;

FIG. 22A is a partial cross-sectional view of an alternative embodimentof a safety catheter in the ready position, wherein the inner member isin a first position relative to the outer member;

FIG. 22B is another partial cross-sectional view of the safety catheterof FIG. 22A in the ready position and 90° offset from the view shown inFIG. 22A;

FIG. 23A is a partial cross-sectional view of the alternative safetycatheter of FIG. 22A in the protected position, wherein the inner memberis in a second position relative to the outer member;

FIG. 23B is another partial cross-sectional view of the safety catheterof FIG. 23A in the protected position and 90° offset from the view shownin FIG. 23A;

FIG. 24 is a perspective view of a safety catheter in accordance withanother embodiment of the invention; and

FIG. 25 is a perspective view of a safety catheter in accordance withyet another embodiment of the invention.

DETAILED DESCRIPTION

In reference to FIGS. 1 and 2, a peripheral intravenous safety catheter10 includes a catheter assembly 12 and a needle assembly 14 nestedrelative to the catheter assembly 12 and configured to provide aninterface with the vasculature of a patient (not shown). The catheterassembly 12 includes a catheter hub 16 and a generally flexible cathetertube 18 coupled to a distal portion of the catheter hub 16 and extendingdistally thereof. The needle assembly 14 includes a needle support orhub 20 and a needle cannula 22 coupled to a distal portion of the needlehub 20 with a needle shaft 23 extending distally of the needle hub 20.As is generally conventional, the needle assembly 14 is positionedrelative to the catheter assembly 12 such that the needle cannula 22 isdisposed within the catheter tube 18 and a distal tip 24 thereof (whichin the embodiment shown is sharp but could alternatively be blunt)extends beyond a distal end 26 of the catheter tube 18 in a readyposition of the safety catheter 10, as illustrated in FIG. 2. A sheath28 may be provided to protect the safety catheter 10 prior to use, suchas during transit to and storage in a medical facility. As will bediscussed in more detail below, safety catheter 10 includes an exemplarytip protector 30 in accordance with various aspects of the presentinvention configured to protect the distal tip 24 of the needle cannula22 when the needle cannula 22 is withdrawn from the catheter hub 16during use.

As illustrated in FIGS. 1 and 19, tip protector 30 is of the typeconfigured to enclose the distal portion of the needle cannula 22,including the distal tip 24, while leaving the more proximal portions ofthe needle shaft 25 exposed. In accordance with one aspect of theinvention, the tip protector 30 is a multi-piece design having axiallyshiftable members that cooperate in a manner to provide improvedshielding of the distal tip 24 of the needle cannula 22, and provideimproved securement/release of the tip protector 30 to and from thecatheter hub 16. Additionally, as illustrated in FIG. 2, the tipprotector 30 may also be of the type configured to be positionedsubstantially within the catheter hub 16, but as shown hereinadvantageously has a relatively small portion extending proximallyoutside thereof.

To this end, the tip protector 30 includes a first, inner member 32received within a second, outer member 34 such that the inner member 32is axially shiftable relative to the outer member 34 between a firstposition and a second position, as will be explained in more detailbelow. In accordance with one aspect of the invention, the inner member32 may be designed with the primary focus of protecting or shielding thedistal tip 24 of the needle cannula 22. This may be achieved, forexample, by blocking the path of the needle cannula 22 once the innermember 32 has been axially shifted to the second position. The outermember 34, on the other hand, may be designed with the primary focus ofsecuring and releasing the tip protector 30 to and from the catheter hub16. While the particular functions of the tip protector 30 may be parsedout to, for example, the inner and outer members 32, 34, it should berecognized that both members 32, 34 are necessary to provide a tipprotecting function in the safety catheter 10.

In one embodiment, and as illustrated in FIGS. 3-5, the inner member 32includes a generally cylindrical body member 36 having a proximal end38, a distal end 40, and a passageway 42 extending between the proximaland distal ends 38, 40. Passageway 42 defines a central axis 44 and isconfigured to receive at least a portion of the needle cannula 22therethrough. The cylindrical body member 36 includes a pair of opposedslots 46 formed through the wall of the body member 36 to define a pairof opposed arms 48 a, 48 b capable of hinging generally inward andoutward relative to the central axis 44. In that regard, the slots 46intersect the distal end 40 of the body member 36 and extend proximallytherefrom. The slots 46 have a proximal end 50 that stop short of theproximal end 38 of the body member 36 to define a generallycircumferentially continuous base member 52. To facilitate hinging ofthe arms 48 a, 48 b, the width of the slots 46 may vary along theirlength so as to, for example, increase in width adjacent to and in adirection toward the proximal end 50 of the slots 46, as shown in FIGS.3 and 4, which operates as the hinge or pivot point for arms 48 a, 48 b.

In one embodiment, and although not so limited, the arms 48 a, 48 b maybe essentially mirror images of each other, and thus a description ofone of the arms (e.g., arm 48 a) will suffice as a description of theother arm (arm 48 b). Arm 48 a includes an inner surface 54, an outersurface 56, and a pair of slot faces 58 formed by the formation of slots46 in body member 36. The outer surface 56 may be contoured tofacilitate operation of the tip protector 30. To this end, the outersurface 56 may include a first angled surface 60 adjacent each of theslot faces 58 and adjacent the proximal end 50 of the slots 46. A groove62 may also be formed adjacent each of the slot faces 58 and includes abottom wall 64, a side wall 66, and a proximal end wall 68 (FIG. 3). Thegroove 62 extends distally from the first angled surface 60 toward thedistal end 40 of the arm 48 a and is open along a distal end thereof.Additionally, at least a portion of the distal end 40 of the arm 48 amay include a slight chamfer 70 formed in the outer surface 56 thereofwhich leads to a distal end face 72 of the arm 48 a.

As shown in FIGS. 3 and 4, the outer surface 56 of arm 48 a may includea raised ridge or boss 74 disposed adjacent the distal end 40 and alongan intermediate portion of arm 48 a (e.g., generally central of the twogrooves 62 and, for example, about ninety degrees offset relative toslots 46). The raised boss 74 defines abutment surfaces 76, the purposeof which is described in more detail below. Moreover, arm 48 a mayinclude a second groove 78 formed along an intermediate portion of arm48 a (e.g., generally aligned with raised boss 74) that has a proximalend adjacent the proximal end 38 of body member 36, and a distal endthat terminates in arm 48 a proximal of raised boss 74. Groove 78includes a bottom wall 80, and a pair of opposed side walls 82. Thegroove 78 may have a depth that varies along its length and may furtherhave a cavity 84 formed in the bottom wall 80 thereof. Cavity 84 definesa first end wall 86 and a second end wall 88. In one embodiment, thefirst end wall 86 may generally form an acute or right angle relative tobottom wall 80, and the second end wall 88 may generally form an obtuseangle relative to the bottom wall 80. In addition to the above, theouter surface 56 of the inner member 32 may include a notch 90 formedadjacent the proximal end 38 and which extends into (e.g., recessed in)the bottom wall 80 of the groove 78.

The inner surface 54 of the inner member 32 may also be contoured tofacilitate operation of the tip protector 30. As shown in FIGS. 3 and 5,the inner surface 54 of arm 48 a includes a generally smooth distaltapered bore portion 92. In other words, the distal tapered bore portion92 includes a generally defined radius of curvature that decreases inthe distal direction (i.e., toward distal end 40). Collectively, thetapered bore portions 92 of both arms 48 a and 48 b define a taperedbore that is a portion of passageway 42 which has a first crossdimension at a first proximal location and a second cross dimension at asecond distal location that is less than the first cross dimension, atleast when the inner member 32 is in its second position relative toouter member 34, as explained in more detail below.

In addition to the above, an inner surface 94 of base member 52 mayinclude an annular rib 96 that generally defines a proximal facing ledge98. While the embodiment shown in FIGS. 3-5 illustrates a single ribthat provides a continuous circumferential ledge, in alternativeembodiments, multiple ribs may be utilized to provide a discontinuousledge (not shown). The ledge 98 generally defines at least in part theboundary of a proximal cavity 100 configured to receive a needle stopmember therein. As discussed in more detail below, the stop member maybe configured to cooperate with the needle cannula 22 during itswithdrawal from the catheter assembly 12 so as to effect relativemovement between the needle cannula 22 and the tip protector 30.

In an exemplary embodiment, the stop member may include a stop washer102 having a distal face 104, a proximal face 106, a side wall 108extending between the distal and proximal faces 102, 104, and a centralaperture 110 also extending between the distal and proximal faces 102,104 (FIG. 3). The stop washer 102 is generally characterized by thelength “1” of the side wall 108 being less than, and preferablysignificantly less (such as about ⅕ to 1/7) than a cross-dimension “c”(e.g., diameter or effective diameter) of the distal and proximal faces104, 106. As also illustrated in FIG. 3, in one embodiment, the stopwasher 102 may include at least one leg 112 (one shown) coupled to theside wall 108 and extending distally thereof. While the stop washer 102is advantageous in many applications, other stop members may be usedincluding, for example, a tubular sleeve. However, a sleeve is axiallyelongated as compared to a washer and may have certain drawbacks thatmay not be desirable in certain applications.

When the stop washer 102 is positioned within proximal cavity 100, thedistal face 104 thereof is configured to engage the ledge 98 formed bythe rib 96. This engagement prevents or limits distal movement of thestop washer 102 relative to the inner member 32. The stop washer 102 maybe captured within cavity 100 by suitable formation of the proximal end38 of the body member 36. To this end, the proximal end 38 includes aproximal end face 114 having an opening 116 formed therein. The opening116 has a cross dimension (e.g., diameter) that is smaller than a crossdimension of the stop washer 102. Accordingly, the end face 114 operatesto prevent or limit proximal movement of the stop washer 102 relative tothe inner member 32.

In addition to the above, when the stop washer 102 is disposed withinproximal cavity 100, the leg 112 is configured to be received within thenotch 90 formed adjacent the proximal end 38 of the body member 36, asillustrated in FIG. 4. The purpose of the leg 112 (and thus the notch 90that receives leg 112) is primarily directed to facilitating assembly ofthe safety catheter 10 through an automated manufacturing process. Theleg 112 and notch 90 otherwise have no role in the proper functioning ofthe tip protector 30. Accordingly, those of ordinary skill in the artwill realize that the leg 112 and the notch 90 that receives the leg inan assembled condition may be omitted without negatively affecting theoperation of the safety catheter 10 depending on the particularrequirements or preferences of an assembly process.

The body member 36 of inner member 32 may be formed from suitablematerials including various metals and plastics. By way of example, thebody member 36 may be formed from such materials as polypropylene,polyethylene, polyoxymethylene (acetal), polycarbonate and nylon. In oneaspect, the body member 36 may be formed from plastics or othermaterials suitable for molding processes including, for example, variousinjection molding processes. In an exemplary embodiment, the innermember 32 may be formed from plastic through a molding process so as todefine the multi-thickness member shown herein. The stop washer 102 mayalso be formed from suitable materials including various metals andplastics. The stop washer 102 may be generally more rigid than the bodymember 36 and advantageously may be formed from medical grade stainlesssteel or other metals. In this regard, the use of a more rigid materialat the location of engagement between the needle cannula 22 and theinner member 32 reduces the risk of the plastic inner member fromdeforming and allowing the needle cannula 22 to be pulled from the tipprotector 30.

The stop washer 102 may be assembled with the body member 36 duringmanufacturing or during a post-manufacturing process of inner member 32.By way of example, the stop washer 102 may be assembled with body member36 in an over-molding process. In that regard, the stop washer 102 maybe suitably located within a mold assembly as an insert. The moldassembly is then closed and the resin that forms the body member 36 isinjected into the mold so as to form about the insert. In anotherembodiment, the body member 36 may be injection molded without the stopwasher 102 being assembled therewith. In this method, the proximal end38 thereof may lack the proximal end face 114 and instead be formed asan open ended tubular extension of cavity 100 (FIG. 3). Subsequent tothe molding operation of body member 36, the stop washer 102 may bepositioned within the cavity 100 and the proximal end 38 processed toform proximal end face 114. By way of example, a swaging or othersimilar process may be utilized to form the proximal end face 114. Thoseof ordinary skill in the art may recognize other processes formanufacturing and/or assembling the inner member 32 and aspects of theinvention are not limited to those described herein.

Turning to the outer member 34 illustrated in FIGS. 6-8, in oneembodiment, the outer member 34 includes a body member 118 which isshown here to be a thin-walled generally cylindrical body member 118.Body member 118 has a proximal end 120, a distal end 122, and apassageway 124 extending between the proximal and distal ends 120, 122.The passageway 124 defines a central axis 126 and is configured toreceive at least a portion of the inner member 32 as well as at least aportion of the needle cannula 22. When the inner and outer members 32,34 are movably coupled in the manner described below, the central axes44, 126 may be configured to be generally colinear. Outer member 34includes a number of features that facilitates operation of tipprotector 30 through cooperation with the inner member 32 as well aswith the catheter hub 16.

In that regard, cylindrical body member 118 includes a pair of opposed,generally rectangular openings or cutouts 128 formed through the wall ofthe body member 118 adjacent, but spaced from, the distal end 122thereof. In one embodiment, engagement portions in the form of at leastone generally flexible tab 130 may be generally disposed in one or eachof the cutouts 128. For example, in one embodiment, two tabs 130 may begenerally disposed in each of the cutouts 128, as shown in FIGS. 6 and7. In an alternative embodiment, however, one tab 130 may be generallydisposed in each of the cutouts 128 (not shown). In a furtheralternative embodiment, one or two flexible tabs 130 may be generallydisposed in only one of the cutouts 128. Other combinations may also bepossible. Each of the flexible tabs 130 has a J-shaped configurationwith a proximal end 132 thereof coupled to a proximal end 134 of acorresponding cutout 128.

In one embodiment, a distal end 136 of the flexible tabs 130 may becurved or hooked in a generally inward direction relative to centralaxis 126 so as to define an abutment surface 138 on an outer surface ofthe tabs 130 and terminate along a contacting edge 140 inward of theabutment surface 138 (FIG. 8). While the flexible tabs 130 are shown asbeing curved or hooked in a generally inward direction, in analternative embodiment, the flexible tabs 130 may be curved or hooked ina generally outward direction relative to central axis 126 such that thecontacting edge 140 is directed outwardly (not shown). As will beexplained in more detail below, the flexible tabs 130 may extendradially outward of the cylindrical body member 118 so as to cooperatewith the catheter hub 16 and releasably secure the tip protector 30thereto.

In addition to cutouts 128, the outer member 34 may include at leastone, and preferably a second pair of opposed, generally rectangularopenings or cutouts 142 formed through the outer wall of the body member118 adjacent, but spaced from, the distal end 122 thereof. In oneembodiment, the cutouts 142 may be about ninety degrees offset from thecutouts 128 (e.g., about central axis 126) and may be located slightlydistally of cutouts 128, although not so limited. Cutouts 142 define aproximal edge 144, a distal edge 146, and a pair of side edges 148 (FIG.8). As will be explained in more detail below, the cutouts 142 areconfigured to receive the raised bosses 74 on the inner member 32 whenthe safety catheter 10 is in the ready position.

The outer member 34 may further include at least one, and preferably apair of opposed, generally rectangular indentations 150 formed in theouter wall of the body member 118. The indentations 150 may be generallyaxially aligned with cutouts 142 (e.g., about ninety degrees offset fromthe cutouts 128) and positioned proximally thereof. As can beappreciated, the indentations 150 formed on the outer surface of bodymember 118 result in projections relative to the inner surface of thebody member 118 that defines engaging surfaces 152 that extend away froman inner surface and into the passageway 124 of the outer member 34. Theindentations 150, in effect, define a reduced cross dimension portion ofpassageway 124 and are configured to cooperate with the inner member 32in a manner to be described in more detail below. A hole 154 may beformed in at least one of the indentations 150. Similar to above, thehole 154 plays no role in the functioning of tip protector 30. Instead,hole 154 may facilitate assembly, such as providing a visual aid duringthe assembly process of the catheter device 10. Again, depending on theparticular assembly process, the hole 154 may be omitted withoutnegatively impacting the operation of tip protector 30.

In addition to the above, the outer member 34 may include at least one,and in an exemplary embodiment, a pair of opposed slots 156 in bodymember 118 which extend in a generally proximal-distal direction and aregenerally axially aligned with the cutouts 142 and indentations 150 ofouter member 34. The slots 156, however, may be positioned generallyproximally of indentations 150. A generally flexible locking tab 158 maybe generally disposed in the at least one slot 156, and preferably ineach of the slots 156. In that regard, the flexible locking tabs 158 maybe coupled to a distal end 160 of the slots 156 and extend proximally,but stop short of the proximal end 162 of slots 156. Each of theflexible locking tabs 158 may include a distal tab portion 164, aproximal tab portion 166, and an intermediate tab portion 168. Thedistal tab portion 164 may be configured to generally lie within theslot 156 (e.g., within the perimeter of the outer member 34), althoughnot so limited. The intermediate tab portion 168, however, may begenerally arcuate so as to define an offset between the distal tabportion 164 and the proximal tab portion 166. In this regard, theproximal tab portion 166 may be positioned generally inward of distaltab portion 164 relative to central axis 126 of outer member 34 so as toproject into passageway 124. The proximal tab portion 166 terminates ina contacting edge 170, the purpose of which is to be described in moredetail below.

Adjacent the proximal end 120 of outer member 34 is a generallyoutwardly extending flange 172. In one embodiment, the flange 172 iscircumferentially continuous (e.g., annular). In an alternativeembodiment, the flange 172 may be circumferentially discontinuous anddefine one or more flange portions that project generally outwardly frombody member 118 (not shown). Flange 172 defines a generallydistally-facing lip 174 and a generally proximally-facing lip 176. Asdiscussed in more detail below, the flange 172 may be configured tocooperate with the catheter hub 16 during use. The flange 172 may alsobe configured to cooperate with the needle hub 20, as discussed below.The proximal end 120 of body member 118 may further include a generallycylindrical extension portion 178 proximal of the flange 172. Theextension portion 178 terminates in a generally conical proximal endface 180 having an opening 182 configured to receive at least a portionof the needle cannula 22 therethrough. In one embodiment, the proximalend face 180 may be formed by a plurality of inwardly directed tabs 184(four shown) that define the opening 182.

The cylindrical body member 118 of outer member 34 may be formed fromsuitable materials including various metals and plastics. In anadvantageous aspect, the body member 118 may include a thin-walledcylinder formed from sheet stock metals capable of being formed into agenerally cylindrical member. Such metals include medical gradestainless steels (e.g., 410 stainless steel, 17-7 stainless steel, etc.)with or without heat treatment or other processing to achieve a suitablehardness or other desired characteristics. In an exemplary embodiment,the outer member 34 may be formed through a stamping process of thesheet stock, which stamped material is then put through a rollingprocess to form the outer member 34. The edges of the rolled materialmay then be joined through a suitable process including welding, bondingor other process. In one embodiment, the edges may include interlockingfeatures to enhance the securement of the edges to form the cylindricalbody (e.g., a zipper configuration). Those of ordinary skill in the artmay recognize other processes for forming outer member 34 or forcoupling the edges to form a generally cylindrical shape. In contrast toprevious designs, the outer member 34 has a thin-walled (butsufficiently strong) design that provides increased space for the innermember (e.g., bulkier, plastic inner member).

As described above, the needle assembly 14 generally includes needle hub20 and needle cannula 22 coupled to a distal portion of needle hub 20with a needle shaft 23 extending distally thereof. As shown in moredetail in FIGS. 9 and 10, the needle hub 20 may include a generallycylindrical body member 186 having a distal nose 188, a proximal tubularportion 190, and a generally outwardly extending intermediate flange 192disposed therebetween. The distal nose 188 may be configured to receivetherein and secure thereto a proximal portion of the needle cannula 22.The distal nose 188 may further include a plurality of circumferentiallyspaced spines 194 (four shown) that extend in a generallyproximal-distal direction therealong. The spines 194 provide increasedstrength to the needle hub 20 and may further facilitate assembly of thesafety catheter 10. At least one, and preferably each of the spines 194extends beyond a distal end 196 of nose 188 to define an inner surface198 and a generally distally-directed end face 200. Additionally, adistal end of inner surface 198 may include a taper or bevel 202.

The proximal tubular portion 190 defines an interior chamber 204 that isin fluid communication with a lumen of the needle cannula 22 such thatthe chamber 204 may operate as a flash chamber for the safety catheter10, as is generally known in the art. A flash plug 206 closes off thechamber 204 and is configured to allow gases to pass therethrough whileretaining liquid, such as blood and other bodily fluids, within chamber204. In one embodiment, an outer surface 208 of the proximal tubularportion 190 is generally smooth. In an alternative embodiment, however,the outer surface 208 may include grip-enhancement features, such asvarious depressions or projections that facilitate gripping of theneedle hub 20 by a user (not shown). In such a case, the ridges 210 onflash plug 206 may be oriented relative to the proximal tubular portion190 so as to generally axially align with any such grip-enhancementfeatures.

The intermediate flange 192 may be generally disposed between and extendgenerally outwardly of the distal nose 188 and the proximal tubularportion 190. In one embodiment, intermediate flange 192 may be generallydisc-shaped and include a distal end face 212 and a proximal end face214. The spines 194 on distal nose 188 may extend from distal end face212, as shown. In one aspect, the intermediate flange 192 may beconfigured to cooperate with the sheath 28 that protects the safetycatheter 10 during transit and storage. In that regard, the proximalopening 216 in sheath 28 (FIG. 1) may include one or more tabs (notshown) that provide a snap-fit feature between the needle hub 20 andsheath 28. More particularly, when the needle hub 20 is inserted intothe sheath 28, the tabs at proximal opening 216 may be configured toengage the proximal end face 214 of intermediate flange 192 to securethe more distal portions of needle assembly 14 (and the catheterassembly 12 as well) within the sheath 28.

As shown in these figures, the needle cannula 22 includes a generallystraight, cylindrical and smooth needle shaft 23, a distal portion ofwhich includes a bevel 220 that defines distal tip 24 to be sharp. Theneedle cannula 22 may be formed from suitable medical grade materials,such as stainless steel or other suitable materials, and the bevel220/distal tip 24 may be formed in shaft 23 through conventionalprocesses generally known in the art. However, as best illustrated inFIGS. 1, 11 and 12, the needle cannula 22 may include an engagementfeature adjacent a distal end thereof configured to cooperate with theinner member 32 to axially shift the inner member 32 from the firstposition to the second position relative to the outer member 34, asdiscussed below. In one exemplary embodiment, the engagement featureincludes a protuberance 222 adjacent a distal end of the needle cannula22 and proximal of bevel 220.

For reasons that will become clearer below, the protuberance 222 definesa cross dimension that is greater than a cross dimension of the needleshaft 23 proximal of the protuberance 222. In one embodiment, theprotuberance 222 may be formed through a pressing or pinching process.To this end, opposed pressing members (not shown) may press against theneedle shaft 23 so as to generally decrease a cross dimension thereof ina first transverse direction t₁. As illustrated in FIG. 12, the pressingof the needle shaft 23 in the first transverse direction t₁ causes acorresponding bulge or increase in a cross dimension of the needle shaft23 in a second transverse direction t₂, which may, for example, be aboutninety degrees offset from the first transverse dimension t₁. Thepressing process described above is only one exemplary method forforming the protuberance 222 on needle cannula 22. Those of ordinaryskill in the art may recognize other processes that result in aprotuberance 222 having a cross dimension that is greater than a crossdimension of the needle shaft 23 proximal thereof. The engagementfeature may be integrally formed with needle cannula 22 (such asdescribed above) or may be formed by fixing a separate element to theneedle shaft 23. For example, a ring member (not shown) may be welded,bonded or otherwise secured to needle shaft 23 to form protuberance 222.

As shown in more detail in FIGS. 13-15, the catheter assembly 12includes a catheter hub 16 and a catheter tube 18 coupled to a distalportion of catheter hub 16 and extending distally thereof. For example,as is generally known in the art, the proximal end of the catheter tube18 may be coupled to a metal eyelet 224, which eyelet 224 is then pressfit within a distal cavity 226 of the catheter hub 16. The catheter hub16 defines a proximal cavity 228 open to the proximal end 230 thereofand having a first proximal portion 232 which may be shaped according toLuer taper standards. The first proximal portion 232 may include a bevelor chamfer 234 immediately adjacent proximal end 230. In one embodiment,the proximal cavity 228 may include a second proximal portion 236 havinga generally constant cross dimension that is generally greater than(e.g., increased inner diameter) a cross dimension of the first proximalportion 232 adjacent the second proximal portion 236. The secondproximal portion 236 may be defined at least in part by a transitionregion 238, as illustrated in FIG. 15.

As best shown in FIGS. 14 and 15, the transition region 238 defines aretention feature for releasably securing the tip protector 30 to thecatheter hub 16. In one embodiment, the retention feature defines agenerally outwardly extending retention groove 240 formed therein andmay be circumferentially continuous (e.g., an annular groove). In analternative embodiment, however, the groove 240 may be circumferentiallydiscontinuous (e.g., circumferential groove segments). In still afurther embodiment, the proximal cavity 228 may include a singleproximal portion 232 that tapers or is otherwise shaped (according toany applicable standards) in a continuous manner from the proximal end230 (or the end of chamfer 234) to the distal cavity 226 (e.g., nosecond proximal portion 236 or transition region 238) wherein theretention groove 240 is formed within the side wall of the singleproximal portion 232 (not shown). Still further, the retention featurein the catheter hub 16 may have other configurations, including, forexample, a circumferentially continuous or discontinuous generallyinwardly extending retention rib (not shown).

With each of the elements of the safety catheter 10 described above,assembly of the safety catheter 10 will now be described in more detail.In the initial processing steps, the needle assembly 14 and catheterassembly 12 may be formed using methodologies generally known in theart. To that end, and as explained above, the proximal end of the needlecannula 22 may be press fit or otherwise coupled with the distal nose188 of the needle hub 20, and the proximal end of the catheter tube 18may be secured to eyelet 224, and the eyelet 224 secured within thedistal cavity 226 of the catheter hub 16. The flash plug 206 may also beinserted into the proximal end of proximal tubular portion 190 of needlehub 20 so as to close off the interior chamber 204. It should be notedthat as initially assembled, the needle cannula 22 does not haveprotuberance 222 or other engagement feature formed therein or coupledthereto.

In some applications, it may be desirable to orient the needle cannula22 and needle hub 20 in a specific manner. By way of example, tofacilitate insertion of the catheter assembly 12 into a vein or arteryof a patient, the bevel 220 that defines at least in part the distal tip24 to be sharp is generally placed in a face-up position, as illustratedin FIG. 1. In some instances, clinicians may find it difficult to orientthe bevel 220 in the face-up position by visual inspection of the distalportion of the needle cannula 22. To avoid such a difficulty, the needlehub 20 may be provided with an indicator that indicates the orientationof the bevel 220 relative to the needle hub 20. In one embodiment, forexample, the indicator may include a flat 242 formed on the intermediateflange 192 of the needle hub 20 that is generally axially aligned withthe bevel 220 in needle cannula 22. In this way, a clinician only has toidentify the flat 242 on the needle hub 20 to know the orientation ofthe bevel 220. It should be recognized that other indicia, includingvarious numbers, letters, symbols, etc., may be provided as anindicator, and the invention is not limited to the flat 242 shown anddescribed herein.

With the catheter assembly 12 and needle assembly 14 assembled, the tipprotector 30 may be assembled. To this end, the inner and outer members32, 34 may be formed separately and in a manner as described more fullyabove. Additionally, the stop washer 102 may be coupled to the innermember 32 in a manner as described above. Next, the inner member 32 maybe loaded into the outer member 34 by inserting the proximal end 38 ofthe inner member 32 into the passageway 124 of the outer member 34 viaits distal end 122. In one aspect, the inner and outer members 32, 34may be oriented during this loading process. In that regard, the innerand outer members 32, 34 may be oriented such that the cutouts 142,indentations 150 and flexible tabs 158 of the outer member 34 generallyaxially align with the raised bosses 74 and grooves 78 formed on theinner member 32. Such an orientation also provides that the flexibletabs 130 adjacent the distal end 122 of outer member 34 generallyaxially align with the grooves 62 formed in the arms 48 a, 48 b of innermember 32. Such orienting of the inner and outer members 32, 34 isgenerally shown in FIG. 1.

The inner member 32 may be inserted into the outer member 34 until theproximal end 38 thereof is adjacent, but spaced from, the proximal end120 of the outer member 34. In this regard, the inner member 32 may bepartially seated within the outer member 34 and subsequently fullyseated within the outer member 34. For example, in an automatedassembly, it may be desirable to define a pre-assembly position whereinthe inner member 32 is partially seated within the outer member 34(e.g., during movement of the pre-assembled tip protector along theassembly line) and fully seated within the outer member in a separateassembly step. Alternatively, the inner member 32 may be fully seatedwithin the outer member 34 without having a pre-assembly position. Inany event, in this embodiment, the inner member 32 is configured to besubstantially completely within the outer member 34. As noted below inan alternative embodiment, the invention is not so limited.

With the tip protector 30 assembled, the tip protector 30 may bethreaded onto the needle cannula 22 by inserting the distal tip 24thereof into the proximal end of tip protector 30 and more particularlythrough the proximal openings 184, 116 of the outer and inner members34, 32, respectively. The various flexible parts of the inner and outermembers 32, 34 (e.g., arms 48 a, 48 b, flexible tabs 130, etc.) are notbeing unduly constrained, such as by the outer member 34 or catheter hub16, and therefore tip protector 30 may accommodate the insertion of theneedle cannula 22 therethrough. The tip protector 30 is located onneedle shaft 23 generally spaced from the distal tip 24 thereof so as toprovide sufficient space for the formation of the engagement feature,such as protuberance 222. To this end, the protuberance 222 may beformed by a pressing method or other suitable methods as describedabove.

The catheter assembly 12 may then be loaded onto the needle assembly 14such that the tip protector 30 is substantially positioned within thecatheter hub 16, and the needle hub 20 is in proximity to the proximalend 230 thereof. In that regard, the interaction between the flexibletabs 130 and retention groove 240 may provide a snap-fit feature as thetip protector 30 is inserted into the catheter hub 16. The assembly isthen loaded into the sheath 28 via its proximal opening 216 and securedtogether in the manner described above. The safety catheter 10 may thenbe further processed and appropriately packaged in a manner generallyknown in the art. In one embodiment and as noted above, the assemblyprocess described above may be an automated type of process. Theinvention is not so limited, however, as manual or hybrid types ofprocesses may be used for assembly of the safety catheter 10.

FIG. 2 illustrates the catheter device 10 in a ready position whereinthe bevel 220 and distal tip 24 of the needle cannula 22 extend beyondthe distal end 26 of the catheter tube 18, and the safety catheter 10 isready for insertion into the vasculature of a patient. The interactionof the various components of safety catheter 10 when in the readyposition will now be described in reference to FIGS. 16A and 16B. Whenin the ready position, a substantial portion of tip protector 30 ispositioned within the catheter hub 16. In that regard, the tip protector30 is inserted into the catheter hub 16 during assembly until the distalfacing lip 174 of flange 172 engages the chamfer 234 adjacent theproximal end 230 of the catheter hub 16. This engagement prevents thetip protector 30 from moving any further distally within the catheterhub 16. In one embodiment, no portion of the tip protector 30, and moreparticularly, no portion of outer member 34 thereof engages the proximalend 230 of catheter hub 16. In alternative embodiments, however, the tipprotector 30 may additionally or alternatively engage the proximal end230 of catheter hub 16 (not shown). As shown in these figures, a portionof flange 172 and extension portion 178 may project beyond the proximalend 230 of catheter hub 16. The length l₁ of the tip protector 30 thatextends proximal of the proximal end 230 is sufficiently small such thatgripping and manipulating the tip protector 30 with the human hand wouldbe, for all intents and purposes, impractical if not impossible usingthis portion. That portion of the outer member 34 that projects out ofthe catheter hub 16 is covered by the spines 194 and therefore could notbe grasped in any event.

The tip protector 30 may be releasably secured within the catheter hub16 through an interaction between the outer member 34 and the inner wall244 of the catheter hub 16. More particularly, and as best illustratedin FIG. 16A, when in the ready position, the distal end 136 of flexibletabs 130 is positioned adjacent retention groove 240 such that theabutment surface 138 thereof is positioned within the retention groove240. In one embodiment, the flexible tabs 130 may be configured to bebiased generally inward relative to central axis 126 such that, in theirnatural or unbiased state (and without the inner member 32 beingpositioned within outer member 34), the flexible tabs 130 would extendwithin the passageway 124 of outer member 34.

However, due to the presence of the inner member 32 within the outermember 34, the flexible tabs 130 extend generally outward of thecylinder of the outer member 34 and against their bias when the tipprotector 30 is inserted into the catheter hub 16 and in the readyposition. In one embodiment, the flexible tabs 130 may be configuredsuch that the abutment surface 138 makes contact with the inner wall 244of the catheter hub 16 when in the ready position. Alternatively,however, the flexible tabs 130 may be configured such that the abutmentsurface 138 is positioned in the retention groove 240, but spaced fromthe inner wall 244 of the catheter hub 16. In such an embodiment, shouldthe tip protector 30 be moved proximally away from the catheter hub 16(i.e., should the tip protector 30 be prematurely pulled out of thecatheter hub 16), the abutment surface 138 would contact the wall of theretention groove 240 and restrict further proximal movement.

While in an exemplary embodiment, the flexible tabs 130 are biasedgenerally inwardly, in an alternative embodiment, the flexible tabs 130may be configured to be biased generally outward relative to centralaxis 126 such that, in their natural or unbiased state, the flexibletabs 132 extend away from the passageway 124 of outer member 34. In thisembodiment, the flexible tabs 130 may be configured such that theabutment surface 138 makes contact with the inner wall 244 of thecatheter hub 16 when in the ready position. Alternatively, however, theflexible tabs 130 may be configured such that the abutment surface 138is positioned in the retention groove 240, but spaced from the innerwall 244 of the catheter hub 16 when in the ready position. In eitherembodiment, such a positioning relative to the retention groove 240 isindependent of the position of the inner member 32.

In reference to the exemplary embodiment, although the flexible tabs 130are capable of moving out of retention groove 240 (e.g., under their ownbias), at least when in the ready position, it should be realized thatthe flexible tabs 130 are impeded from moving generally radially inward(and away from retention groove 240) by the presence of a portion of theinner member 32, which is in its first position relative to outer member34 in the ready position of catheter device 10. In that regard, as shownin FIG. 16A, when in the ready position, an inner surface 246 of theflexible tabs 130 may be in close proximity to the bottom wall 64 ofgrooves 62. For example, in one embodiment, the inner surface 246 offlexible tabs 130 may be configured to engage the bottom wall 64, whilein an alternative embodiment, the inner surface 246 of flexible tabs 130may be slightly spaced from the bottom wall 64. As can be appreciated,in such an alternative embodiment, the slight spacing cannot be so greatas to allow the flexible tabs 130 to move out of the retention groove240 without being impeded by the inner member 32. In the variousembodiments, attempts to pull the tip protector 30 out of the catheterhub 16 would require the flexible tabs 130 to move radially inward to anextent that allows them to come away from retention groove 240. Suchradially inward movement, however, is impeded due to the presence of theinner member 32 and the tip protector 30 remains secured to the catheterhub 16.

As further illustrated in FIGS. 16A and 16B, when in the ready position,the inner member 32 is in its first position relative to outer member 34and is entirely positioned within the outer member 34. In oneembodiment, the arms 48 a, 48 b may be configured to be biased generallyradially outward relative to central axis 44. For example, the outermember 34 may be configured to constrain the arms 48 a, 48 b (i.e., butfor the outer member 34, the arms 48 a, 48 b would move further apartfrom one another). When in the ready position, the inner surface 54 ofthe arms 48 a, 48 b may be in proximity to an outer surface 248 of theneedle shaft 23. For example, in one embodiment, the inner surface 54 ofthe arms 48 a, 48 b may be configured to engage the outer surface 248 ofthe needle shaft 23. In an alternative embodiment, however, the innersurface 54 of arms 48 a, 48 b may be slightly spaced from the outersurface 248 of the needle shaft 23. This may, for example, provide for areduced drag force on the needle cannula 22 as it is being pulledproximally during use.

While in one embodiment, the arms 48 a, 48 b are biased generallyradially outward, in an alternative embodiment, the arms 48 a, 48 b maybe configured to be biased generally radially inward relative to centralaxis 44. In such an embodiment, the inner surface 54 of arms 48 a, 48 bmay be configured to engage the outer surface 248 of the needle shaft 23and may be moved generally radially outward due to the presence of theneedle cannula 22 extending through inner member 32 (e.g., the needlecannula 22 moves the arms 48 a, 48 b radially outward against the bias).

Additionally, the locking tabs 158 of the outer member 34 may be biasedgenerally inward relative to central axis 126. More particularly, whenin the ready position, and the inner member 32 is in its first positionrelative to outer member 34, the locking tabs 158 may be configured toengage the bottom wall 80 of groove 78. This engagement may serve acouple of purposes including, for example, providing a resistance forceto movement of the inner member 32 relative to the outer member 34during the initial proximal movement of the needle cannula 22 as it isbeing withdrawn. The engagement between the locking tabs 158 and groove78 may further provide an anti-rotation feature between the inner andouter members 32, 34.

As discussed above, the inner and outer members 32, 34 are orientated ina specific manner during assembly so as to provide proper operation ofthe tip protector 30. Accordingly, it would be undesirable to haverelative rotation therebetween during use of the safety catheter 10. Forexample, it would be undesirable to allow the inner member 32 to rotaterelative to outer member 34 with rotation of the needle cannula 22. Inthat regard, the tip protector 30 may be designed to permit rotation ofthe needle cannula 22 without causing rotation of the tip protector 30(i.e., the needle cannula 22 is free to rotate relative to the tipprotector 30). Additionally, even if, through friction forces, rotationof the needle cannula 22 would tend to rotate the inner member 32 (orthe outer member 34), relative rotation between the inner and outermembers 32, 34 is restricted by the interaction of several features. Forexample, as noted above, engagement of the locking tabs 158 with grooves78 provides a restriction to relative rotation between the inner andouter members 32, 34. More particularly, if relative rotation betweenthe inner and outer members 32, 34 were initiated, the side edges of theflexible tabs 158 would contact the side walls 82 of grooves 78 andtherefore resist the relative rotation.

Additionally, as shown in FIG. 16B, when in the ready position, theraised bosses 74 on the inner member 32 may be received within thecutouts 142 in the outer member 34 such that, for example, the outersurface of the raised bosses 74 is substantially flush with the outersurface of the outer member 34. The invention is not so limited as theraised bosses 74 may extend beyond the periphery of the outer member 34in alternative embodiments. In any event, if relative rotation betweenthe inner and outer members 32, 34 were initiated, the side abutmentsurfaces 76 of raised bosses 74 would contact the side edges 148 ofcutouts 142 and therefore resist the relative rotation.

In addition to preventing relative rotation between the inner and outermembers 32, 34, the raised bosses 74 and cutouts 142 may also resistaxial movement of the inner member 32 relative to the outer member 34 inat least one direction. More particularly, the distal abutment surface76 on raised bosses 74 and distal edge 146 of cutout 142 provide apositive stop that prevents the inner member 32 from axially shiftingdistally relative to the outer member 34 when in the ready position.

In addition to the above, the safety catheter 10 may be designed toallow the tip protector 30 to rotate relative to the catheter hub 16.However, rotation of the tip protector 30 relative to the catheter hub16 would similarly not cause relative rotation between the inner andouter members 32, 34 due to the interaction between the featuresdescribed above. Thus, in accordance with embodiments of the invention,the needle cannula 22 is free to rotate relative to the tip protector 30and the tip protector 30, is free to rotate relative to the catheter hub16.

As further shown in FIGS. 16A and 16B, when in the ready position, thespines 194 on needle hub 20 may be disposed about the flange 172 andextension portion 178 that extend beyond the proximal end 230 of thecatheter hub 16. Additionally, in one embodiment, the end face 200 ofthe spines 194 may be configured to engage the proximal end 230 of thecatheter hub 16. Moreover, when in the ready position, the needle hub 20may be configured to engage or alternatively be spaced from the tipprotector 30. By way of example, in one embodiment, the inner surface198 of the spines 194 may engage the outer surface 250 of extensionportion 178. Additionally, or alternatively, the taper 202 adjacent thedistal end of spines 194 may engage the proximally facing lip 176 offlange 172. Furthermore, the end of distal nose 188 may additionally oralternatively engage the end face 180 of outer member 34.

After the safety catheter 10 is inserted into the artery or vein of thepatient, the needle hub 20, and thus the needle cannula 22, may be movedproximally relative to the catheter assembly 12 and tip protector 30.However, the safety catheter 10 is configured such that drag forcesimposed on the tip protector 30 due to the proximal movement of theneedle cannula 22 are not sufficient to overcome the forces retainingthe tip protector 30 to the catheter hub 16. Accordingly, the tipprotector 30 remains secured to the catheter hub 16 during at least theinitial proximal movement of the needle cannula 22.

Additionally, the drag forces imposed on the inner member 32 of tipprotector 30 due to the proximal movement of the needle cannula 22 arenot sufficient to axially shift the inner member 32 relative to theouter member 34. In this regard, the engagement between locking tabs 158and the bottom wall 80 of grooves 78, the engagement between theflexible tabs 130 and the bottom wall 64 of grooves 62, the resistanceto movement of the inner member 32 relative to the outer member 34 dueto the generally outwardly biasing of the arms 48 a, 48 b (e.g.,engagement between the raised bosses 74 on arms 48 a, 48 b and theproximal edge 144 of cutout 142), or other sources, provides a resistiveforce that is greater than the drag forces imposed on the inner member32 due to proximal movement of the needle cannula 22. Accordingly, theinner member 32 does not move proximally relative to the outer member 34during at least this initial proximal movement of the needle cannula 22.

As the needle hub 20 and needle cannula 22 are moved further in theproximal direction, the distal tip 24 thereof moves proximal of thedistal end 122 of the outer member 34 and proximal of the distal end 40of the inner member 32, which is disposed within the outer member 34.Such a positioning of distal tip 24 relative to inner member 32 andouter member 34 is best illustrated in FIGS. 17A and 17B. Note thatalthough the needle cannula 22 no longer blocks the arms 48 a, 48 b, thearms 48 a, 48 b do not move radially inward (due to their outward bias).Thus, at this point, the raised bosses 74 of the inner member 32 remainin the cutouts 142 of the outer member 34. If the arms 48 a, 48 b werebiased generally radially inward toward central axis 44, as in one ofthe alternative embodiments discussed above, positioning the distal tip24 within the inner member 32 as shown in these figures would allow thearms 48 a, 48 b to close radially inward under their own bias due to theabsence of the needle cannula 22 between the distal portion of the arms48 a, 48 b. However, in such an alternative embodiment, the closing downof the arms 48 a, 48 b radially inward would not otherwise affect therelease of the tip protector 30 from the catheter hub 16 or affect thelack of axially movement of the inner member 32 within the outer member34.

With reference to FIGS. 17A and 17B, as the needle hub 20 and needlecannula 22 are moved further in the proximal direction, and with thedistal tip 24 positioned within the inner member 32 so as to not blockthe radially inward movement of the arms 48 a, 48 b, the protuberance222 is configured to engage the stop washer 102. In this regard, theportion of the needle shaft 23 proximal of protuberance 222 is sized soas to pass through the central aperture 110 in stop washer 102, passthrough the opening 116 in the proximal end face 114 of inner member 32,and pass through the opening 182 in the proximal end face 180 of outermember 34. A cross dimension of protuberance 222, however, is sized tobe greater than the cross dimension of the central aperture 110 in stopwasher 102. Thus, when the protuberance 222 engages the stop washer 102,further proximal movement of the needle cannula 22 relative to the innermember 32 is thereby restricted.

Accordingly, with further proximal movement of the needle hub 20 andneedle cannula 22, the engagement between the protuberance 222 and stopwasher 102, which is secured within the inner member 32 as describedabove, causes the inner member 32 to be axially shifted proximallyrelative to the outer member 34. As the inner member 32 is pulledfurther proximally within the outer member 34, the inner surface 246 ofthe flexible tabs 130 remains in close proximity to (e.g., engage or beslightly spaced from) the bottom wall 64 of grooves 62. In this way, forexample, even as the inner member 32 is initially axially shiftedrelative to the outer member 34, the presence of the inner member 32still impedes the flexible tabs 130 from moving generally inward so asto come away from retention groove 240. Accordingly, during at least theinitial axial shifting of the inner member 32 relative to the outermember 34, the outer member 34, and thus the tip protector 30, remainssecured to the catheter hub 16.

In addition to the above, during at least this initial axial shifting ofthe inner member 32 relative to the outer member 34, an inner surface252 of flexible tabs 158 engages and slides along the bottom wall 80 ofgroove 78. Additionally, during the axial shifting of the inner member32 within the outer member 34, the cammed proximal surface of the raisedbosses 74 engage the proximal edge 144 of cutouts 142 and causes thearms 48 a, 48 b to move generally radially inward so as to essentiallyclose down against their bias such that the raised bosses 74 are nolonger received in the cutouts 142, but are within the confines of theouter member 34 proximal of cutouts 142. Moreover, the raised bosses 74and the indentations 150 are generally axially aligned such that theaxial shifting of the inner member 32 away from its first positioncauses the raised bosses 74 to contact the engaging surfaces 152 of theindentations 150, which project into the passageway 124 of the outermember 34. This engagement, in turn, causes the arms 48 a, 48 b to closedown (i.e., move radially inward toward each other) even further.

Regardless of the particular embodiment, it should be recognized thatthe drag forces imposed on the outer member 34 by axial shifting of theinner member 32 is less than the retentive force imposed between theouter member 34 and the catheter hub 16, such as via the retentive forceimposed between the flexible tabs 130 and the retention groove 240 andthe inability of the flexible tabs 130 to move away from the retentiongroove 240 due to the presence of the inner member 32 relative thereto.This relationship in the various forces allows the inner member 32 to beaxially shifted relative to the outer member 34 without the outer member34, and thus the tip protector 30, from being prematurely pulledproximally out of the catheter hub 16.

With reference to FIGS. 18A and 18B, as the inner member 32 continues tobe axially shifted proximally within the outer member 34, the proximaltab portion 164 of locking tabs 158 drops into cavity 84 formed in thebottom wall 80 of groove 78 (FIG. 18B) due to the generally inward biasof locking tabs 158. When the proximal tab portion 164 drops into cavity84, distal axial shifting of the inner member 32 relative to the outermember 34 is restricted by engagement between the contacting edge 170 oflocking tabs 158 and the first end wall 86 of cavity 84 (i.e., the innermember 32 cannot be pushed out of the outer member 34). Furthermore,when the proximal tab portion 164 drops into cavity 84, the proximal end38 of the inner member 32 may be in close proximity to the proximal end120 of the outer member 34. In this regard, the opening 182 in theproximal end 120 of outer member 34 is sized so as to prevent the innermember 32 from passing therethrough.

Thus, the proximal end 120 of outer member 34 operates as a stop thatprevents further proximal axial shifting of the inner member 32 relativeto the outer member 34. In this way, when the proximal tab portion 164drops into cavity 84, proximal and distal axial shifting of the innermember 32 relative to the outer member 34 is substantially restrictedand the inner and outer members 32, 34 are essentially locked together.In that regard, the locking tabs 158 and cavity 84 operate as a lockingmechanism that restricts axial shifting of the inner member 32 relativeto the outer member 34 in the distal direction. Similarly, the sizing ofopening 182 in the proximal end 120 of outer member 34, so as to blockpassage of inner member 32 therethrough, may also operate as a lockingmechanism to restrict proximal axial shifting of the inner member 32relative to the outer member 34.

In one embodiment, the outside surface of proximal end face 114 of innermember 32 may engage the inside surface of proximal end face 180 ofouter member 34 at nearly the same time that the proximal tab portion164 drops into cavity 84, such that there is essentially no play betweenthe inner and outer members 32, 34 when the proximal tab portion 164drops into cavity 84. In an alternative embodiment, however, and asillustrated in FIGS. 18A and 18B, the proximal end 38 of the innermember 32 may be slightly spaced from the proximal end 120 of the outermember 34 when the distal tab portion 164 drops into cavity 84. In suchan embodiment, additional proximal axial shifting of the inner member 32relative to the outer member 34 may be permitted before the proximalends 38, 120 of the inner and outer members 32, 34, respectively, engageeach other. In other words, although the inner and outer members 32, 34are essentially locked together, a certain amount of play may existbetween the two members 32, 34 after being locked together. In anyevent, the inner member 32 is positioned so as to shield the distal tip24 of needle cannula 22.

After the proximal tab portion 164 drops into the cavity 84 (in whichthe proximal ends 38, 120 of the inner and outer members 32, 34 may ormay not engage as explained above), the inner member 32 is in a secondposition relative to the outer member 34 wherein the inner member 32 nolonger blocks the movement of the flexing tabs 130 radially inward dueto their bias. Accordingly, when the inner member 32 is in the secondposition, the flexible tabs 130 are permitted to move radially inwardand away from the retention groove 240 so as to release the tipprotector 30 from the catheter hub 16. Although the positioning of theinner member 32 so as to no longer block the flexible tabs 130 of theouter member 34 occurs after the proximal tab portion 164 drops into thecavity 84, such positioning does not necessarily occur simultaneously.

In that regard, in one embodiment, indeed, the inner member 32 may bepositioned so as to no longer block the movement of the flexible tabs130 of the outer member 34 at substantially the same time that theproximal tab portions 164 drop into the cavity 84. In an alternativeembodiment, however, the proximal tab portions 164 may drop into thecavity 84, but the inner member 32 may have an intermediate position inwhich it is still positioned so as to block the movement of the flexibletabs 130 away from the retention groove 240 and impede release of thetip protector 30 from the catheter hub 16. It is only with furtherproximal axial shifting of the inner member 32 relative to the outermember 34, and before or simultaneous with the proximal end face 114 ofinner member 32 engaging the proximal end face 180 of outer member 34,that the inner member 32 is in the second position and no longer blocksthe movement of the flexible tabs 130 such that the tip protector 30 maybe removed from the catheter hub 16.

When the inner member 32 no longer blocks the movement of the flexibletabs 130, the tabs 130 move radially inward under their own bias andaway from the retention groove 240. In one embodiment, the abutmentsurface 138 of the flexible tabs 130 may be completely removed from theretention groove 240 such that there is no tug force required to removethe tip protector 30 from the catheter hub 16 (e.g., passive release).In this embodiment, the flexible tabs 130 may move radially inward suchthat at least a portion of the tabs 130 drop in front of the innermember 32. More particularly, the contacting edge 140 of the tabs 130may engage or confront (e.g., be slightly spaced from) the distal endface 72 of the inner member 32, when the inner member 32 no longerblocks the tabs 130.

In an alternative embodiment, the flexible tabs 130 may move radiallyinward under their own bias when no longer blocked by the inner member32, but by an amount that does not completely remove the abutmentsurface 138 from the retention groove 240. In this embodiment, when thetip protector 30 is removed from the catheter hub 16, the abutmentsurface 138 will slightly contact the retention groove 240 causing theflexible tabs 130 to move slightly radially inward and out of theretention groove 240. This will result in a relatively small tug forcein order to remove the tip protector 30 from the catheter hub 16.

While the operation has been described above for the flexible tabs 130being biased generally radially inward relative to central axis 126, oneof ordinary skill in the art will readily understand operation of thetip protector 30 when the flexible tabs 130 are biased generallyradially outward relative to central axis 126. In this regard, one ofthe primary differences is that when the inner member 32 is in itssecond position and no longer blocking the movement of the tabs 130, thetabs 130 will not move radially inward under a biasing force and awayfrom the retention groove 240 (as was the case above). Instead, theabutment surface 138 will remain engaged or nearly engaged with theretention groove 240. Similar to the above, in this embodiment, when thetip protector 30 is removed from the catheter hub 16, the abutmentsurface 138 will contact the retention groove 240 causing the flexibletabs 130 to move radially inward and out of the retention groove 240(e.g., duckbill type). As the flexible tabs 130 are more fullypositioned relative to the retention groove 240, a larger tug force maybe required in order to remove the tip protector 30 from the catheterhub 16 (e.g., active release). In some applications, such a tug forcemay be undesirable in which case the embodiment having radially inwardbiased flexible tabs 130 may be employed.

FIG. 19 illustrates the needle assembly 14 fully withdrawn from thecatheter assembly 12 (not shown), which remains in fluid communicationwith the vasculature of the patient. As shown, the distal portion of theneedle cannula 22, including the distal tip 24 thereof, is shielded bytip protector 30 while more proximal portions of the needle shaft 23 areexposed. Furthermore, the tip protector 30 is designed to prevent orsignificantly reduce the chance or likelihood of re-exposing the distaltip 24 of the needle cannula 22. As discussed above, once the lockingtabs 158 drop into cavity 80, the inner and outer members 32, 34 areessentially locked together and tip protector 30 is also essentiallylocked onto needle cannula 22. In that regard, should the needle cannula22 be pulled proximally relative to the tip protector 30 (e.g., such asby grabbing the outer member 34 thereof with one hand and pullingproximally on the needle hub 20 with the outer hand), the protuberance222 will act on stop washer 102, which in turn acts on inner member 32.However, as noted above, the proximal end 38 of inner member 32 isengaged with or is in near engagement with the proximal end 120 of outermember 34 so as to effectively prevent the needle cannula 22 from beingpulled proximally out of the tip protector 30.

Similarly, should the needle cannula 22 be pushed distally relative tothe tip protector 30 (e.g., such as by grabbing the outer member 34thereof with one hand and pushing distally on the needle hub 20 with theouter hand), there may be some slight distal movement of the needlecannula 22 relative to tip protector 30. However, with reference toFIGS. 18A and 18B, as the needle cannula 22 moves distally, the needlecannula 22 will contact the inner surface 54 of arms 48 a, 48 b. Moreparticularly, when the inner member 32 is in its second positionrelative to the outer member 34, the cross dimension of passageway 42along a distal portion thereof is smaller than the cross dimension ofthe needle shaft 23 adjacent the distal tip 24. Accordingly, when in thesecond position, the passageway 42 along distal tapered bore portions 92is sized so as to block the path of needle cannula 22 (i.e., the size ofthe distal tapered bore is smaller than the needle cannula 22).Additionally, when in the second position, the arms 48 a, 48 b of innermember 32 are constrained by the outer member 34 (e.g., engagementbetween the engaging surfaces 152 of indentations 150 and the raisedbosses 74), and thus, the arms 48 a, 48 b are not capable of flexinggenerally radially outward so as to increase the size of passageway 42and allowing the needle cannula 22 to pass therethrough.

Furthermore, when distal movement of the needle cannula 22 relative tothe inner member 32 has been blocked, depending on the particularembodiment, it may be possible to axially shift the inner member 32distally relative to the outer member 34. For example, if there is someslight play between the inner and outer members 32, 34 when they areessentially locked together, such relative axial shifting therebetweenmay be possible. However, any such relative axial shifting is small anddistal movement of the inner member 32 relative to the outer member 34is eventually restricted by engagement of the contacting edge 170 oflocking tabs 158 and the first end wall 86 of cavity 84. Accordingly,even though there may be slight relative movement between the needlecannula 22 and tip protector 30, ultimately the distal tip 24 of theneedle cannula 22 is effectively prevented from re-emerging by pushingthe needle cannula 22 distally out of the tip protector 30.

In various alternative embodiments, the inner member may includeadditional features to restrict re-emergence of the needle cannula 22 bypushing the needle cannula 22 distally out of the tip protector 30. Byway of example, when the cross dimension of the needle shaft 23 becomesrelatively small (e.g., 20, 22, and 24 gauge cannulas), the needlecannula 22 may be more susceptible to undesirable flexing and a possibleside-out failure mode. Accordingly, for these larger gauges, it may bedesirable to include features that limit or restrict the amount offlexing of the needle cannula 22 during, for example, a potentialside-out failure mode or other accidental or extreme conditions. To thisend and as illustrated in FIG. 20, the inner member 32′ may includesidebites. More particularly, the sidebites may include one or moreprojections 260 on the inner surface 54 of at least one the arms 48 a,48 b that limit the flexing of the needle cannula 22. In an exemplaryembodiment, at least one of the arms 48 a, 48 b includes a projection260 disposed on opposed sides of the tapered bore portion 92, such asalong slot faces 58, which are increased due to the smaller size oftapered bore portion 92. These projections 260 essentially blockexcessive flexing of the needle cannula 22 in a direction toward theopposed slots 46. In one embodiment, the sidebites may be integrallyformed in the inner member 32′ such as, for example, during molding ofthe inner member 32′.

In order to allow the arms 48 a, 48 b of the inner member 32′ to move toa fully closed position (such as when in the second position), the arms48 a, 48 b, which opposes the projections 260 may include acorresponding notch 262 configured to receive at least a portion of theprojections 260 therein. In an exemplary embodiment, these may also beformed during molding of the inner member 32′. In this way, theoperation of the tip protector 30 is not adversely effected whileproviding an additional feature for restricting re-emergence of theneedle cannula 22 in a potential failure mode or extreme condition. Inany event, should the needle cannula 22 be forced distally relative tothe tip protector 30 and the needle cannula 22 start bending or flexingin a direction toward the opposed slots 46, the needle cannula 22 willcontact the projections 260 and be prevented from any further flexing inthose directions. Of course, any flexing or bending of the needlecannula 22 in directions other than toward the opposed slots 46 would berestricted by engagement with the solid inner surface 54 arms 48 a, 48 bthemselves.

In addition to, or in lieu of, the projections 260 and correspondingnotches 262 described above, various embodiments in accordance with theinvention may include an inner member 32″ having further features torestrict re-emergence of the needle cannula 22 by pushing the needlecannula 22 distally out of the tip protector 30. Again, such additionalfeatures may be desirable for the larger gauge (smaller crossdimensions) needle cannula 22. To this end, and as shown in FIG. 21, theinner surface 54 of at least one of the arms 48 a, 48 b may include oneor more ribs 264 adjacent the distal end 40 of the arms 48 a, 48 bconfigured to further block the path of the needle cannula 22. Forexample, in one embodiment, the ribs 264 may completely close off there-emergence path of the needle cannula 22 from the tip protector 30.The invention, however, is not limited to completely closing off thepath. Similar to above, in an exemplary embodiment, ribs 264 may beformed in inner member 32″ during, for example, molding thereof.

In one exemplary embodiment, one rib 264 a may be located on one of thearms 48 a, 48 b and two adjacent ribs 264 b, 264 c may be located on theother of the arms 48 a, 48 b. When the arms 48 a, 48 b, close down infront of the distal needle tip 24, the ribs 264 a-c may be configured toengage each other. For example, the one rib 264 a may be configured tonest between the two adjacent ribs 264 b, 264 c when the inner member32″ is at least in the second position. In this way, should there be anattempt to move the needle cannula 22 distally relative to the tipprotector 30 (either intentionally or accidentally), the tip 24 thereofwould come into contact with the ribs 264 and be prevented from movingany further distally relative to the tip protector 30.

Those of ordinary skill in the art will recognize that the arrangementof ribs 264 is not limited to the particular arrangement shown anddescribed herein, but encompasses a broad range of rib configurationsdesigned to drop down in front of the distal needle tip 24 and block there-emergence path of the needle cannula 22. It should also be recognizedthat the ribs 264 may be configured such that the ribs 264 do not engagethe needle cannula 22 when in the ready position. In alternativeembodiments, however, it should be recognized that the ribs 264 mayengage and slide along the outer surface 248 of the needle cannula 22during use.

In the various embodiments described above, the inner member 32 remainedwithin the outer member 34 in both the first position (e.g., the readystate of the safety catheter 10) and the second position (e.g., theprotected state of the safety catheter 10). While this may providecertain advantages to enhancing the strength of the tip protector 30 orenhancing the shielding of the distal tip 24 of the needle cannula 22,the invention is not so limited. In this regard, FIGS. 22A-23B in whichlike reference numbers refer to like features in FIGS. 1-19, butsucceeded by the letter a, illustrate an embodiment wherein the tipprotector 30 a includes an inner member 32 a that projects out of theouter member 34 a when in the first position. In this embodiment, theouter member 34 a may be shorter in length as compared to outer member34, for example, truncating near the distal end of flexible tabs 130 a,such that the inner member 32 a projects distally of the outer member 34a in the ready position. Tip protector 30 a operates on similarprinciples as that described above. More particularly, those of ordinaryskill in the art will appreciate that the interaction between the needlecannula 22 a and the inner member 32 a (e.g., stop washer 102 a), theinteraction between the inner member 32 a and the outer member 34 a, andthe interaction between outer member 34 a and catheter hub 16 a remainssubstantially similar. FIGS. 23A and 23B show the tip protector 30 awhen in the protected position. In this position, the inner member 32 ais substantially within the outer member 34 a and the tip protector 30 ais sufficiently secured to the needle cannula 22 a to shield the distaltip 24 a thereof.

FIG. 24 in which like reference numbers refer to like features in FIGS.1-19, but succeeded by the letter c illustrates a further alternativeembodiment of a safety catheter 10 c that is similar to the safetycatheter 10 and includes a tip protector according to various embodimentas previously described above. As will be noted from the figure, thecatheter assembly 12 c includes a pair of wings 270 coupled to thecatheter hub 16 c on one side thereof in a conventional manner (e.g.,patient side). As is generally known in the art, the wings 270 may beused to secure the catheter assembly 12 c to the patient after beinginserted therein using tape, for example.

As illustrated by FIG. 25, the tip protector as described above may alsobe incorporated in a side port catheter design. In this regard, FIG. 25in which like reference numbers refer to like features in FIGS. 1-19,but succeeded by the letter d, includes a safety catheter 10 d that issimilar to the safety catheter 10. The catheter assembly 12 d includes aside port 280 formed therewith having a cover 282 selectively removablefrom the side port 280 for gaining access to the interior chamber 204 dof the catheter hub 16 d. As the construction and operation of a sideport catheter is generally well understood in the art, a more completedescription thereof will be omitted herein. As further shown in FIG. 25,in addition to the side port 280, the catheter assembly may also includea pair of wings 284 coupled to the catheter hub 16 d. As shown, theneedle hub 20 d of catheter assembly 10 d may have a slightly differentdesign. In this regard, the body member 186 d of the needle hub 20 d mayhave a proximal portion 286 and a distal portion 288 being sized largerthan the proximal portion 286 and configured so as to fit over theproximal end 230 d of the catheter hub 16 d. The needle hub 20 d mayalso include a generally radially projecting tab 290 that facilitatesuse of the safety catheter 10 d during, for example, insertion of thecatheter assembly 12 d into the vasculature of a patient.

The sheath 28 d used with catheter insertion device 10 d may also differfrom sheath 28 described above. In this regard, the sheath 28 d mayinclude a straw-like tubular member 292 configured to shield thecatheter tube 18 d and needle cannula 22 d during transit or storage ofthe catheter insertion device 10 d. The proximal end 294 of the tubularmember 292 may be configured to secure to the distal end 296 of theneedle hub 20 d through, for example, a friction fit. As illustrated inFIG. 25, the sheath 28 d may include a plug 298 coupled to a distal end300 of the tubular member 292. In use, the sheath 28 d is removed fromthe catheter device 28 d and the catheter assembly 12 d is inserted intothe patient as described above. After insertion, the plug 298 of sheath28 d may be secured to the proximal end 230 d of the catheter hub 16 d.The plug 298 effectively closes off the proximal end 230 d of thecatheter hub 16 d such that communication between an external device andthe vasculature of the patient is via the side port 280, as is generallyunderstood in the art. Of course, instead of the plug 298 on sheath 28 dbeing used in this capacity, other conventional methods may be used toclose off the proximal end 230 d of catheter hub 16 d. In that case, theplug 298 on sheath 28 d may be omitted.

While the present invention has been illustrated by the description ofembodiments thereof, and while the embodiments have been described inconsiderable detail, it is not intended to restrict or in any way limitthe scope of the appended claims to such detail. Additional advantagesand modifications will readily appear to those skilled in the art.

For example, as discussed above, the interaction between the needlecannula and the inner member to cause movement of the inner memberwithin the outer member includes the protuberance on needle cannula andthe stop washer captured within the inner member. Other arrangements,however, are possible. For example, instead of having an outwardlyprojecting feature (e.g., protuberance 222) on the needle cannula, aninwardly projecting feature, such as an inwardly projecting cavity orgroove may also be used (not shown). In this embodiment, the stop memberassociated with the inner member may be configured to drop into thecavity or groove to provide a positive lock between the inner member andthe needle cannula. Similar to the above, the inner and outer membersmay be effectively locked together when the inner member is in thesecond position to limit relative movement therebetween. Thus, aflexible tab/cavity arrangement may be used to limit distal movement ofthe inner member relative to the outer member. Additionally, an openingin the proximal end of the outer member may be sized to restrict thepassing of the inner member therethrough. It should be realized thatbecause there is a positive lock between the inner member and the needlecannula in such an embodiment, the inner member may no longer need toblock the path of the needle cannula when in the second position.

In addition to the above, depending on the specific application, theinner and outer members may be structurally enhanced so as toaccommodate the stresses and strains imposed thereon during use.Accordingly, various ribbing, ridges, etc., may be selectively used toadd strength in desired areas. By way of example, the outer member mayinclude a containment ring (not shown) on its outer surface to increasethe hoop strength of the outer member. The containment ring may be aseparate element which is coupled to the outer member or be integrallyformed, via material buildup in the desired area, with the outer member.In one embodiment, for example, a containment ring may be disposedadjacent the proximal end of slots, but configured not to interfere withthe operation of the flexible tabs or indentations.

Thus, the invention in its broader aspects is, therefore, not limited tothe specific details, representative apparatus and method, andillustrative examples shown and described. Accordingly, departures maybe made from such details without departing from the spirit or scope ofthe general inventive concept.

Having described the invention, what is claimed is:
 1. A safetycatheter, comprising: a catheter hub and a catheter tube extendingdistally thereof; a needle hub and a needle cannula extending distallythereof, the needle cannula having a distal tip; and a tip protector forshielding the distal tip comprising an outer member and an inner memberbeing axially received within the outer member, the outer memberincluding a projection extending radially outward of the outer memberand sized and configured to releasably engage with an interior of thecatheter hub, the inner member having a pair of arms biased radiallyoutward relative to a central axis and extending distally from a base torespective free ends, the needle cannula being received in the inner andouter members, the inner member, including the pair of arms, configuredto be axially shiftable relative to the outer member between a firstposition wherein the distal tip extends distally of the tip protectorand the free ends of the arms are spread apart such that the distal tipis not shielded, and a second position wherein the distal tip is withinthe inner and outer members and the free ends of the arms are broughtinto close proximity such that the distal tip is shielded, the innermember being entirely received within the outer member in both the firstand second positions thereof.
 2. The safety catheter of claim 1, theouter member further comprising at least one flexible tab, theprojection being part of the at least one flexible tab.
 3. The safetycatheter of claim 2, wherein the at least one flexible tab is biasedradially inward relative to the central axis.
 4. The safety catheter ofclaim 2, wherein the interior of the catheter hub includes a retentiongroove for engaging the projection of the at least one flexible tab. 5.The safety catheter of claim 1, further comprising a locking mechanismconfigured to limit axial shifting of the inner member relative to theouter member when the inner member is in the second position.
 6. Thesafety catheter of claim 1, further comprising an anti-rotationmechanism configured to limit the rotation of the inner member relativeto the outer member.
 7. The safety catheter of claim 1, wherein theinner member is axially shifted from the first position to the secondposition by movement of the needle cannula.
 8. The safety catheter ofclaim 1, wherein the inner member includes a stop member for engaging aportion of the needle cannula to axially shift the inner member from thefirst position to the second position.
 9. The safety catheter of claim8, wherein the needle cannula includes a protuberance adapted to engagethe stop member.
 10. The safety catheter of claim 8, the inner memberbeing plastic, the stop member being a metal washer.
 11. The safetycatheter of claim 1, the inner member including at least one ribassociated with the free end of one of the arms adapted to block thepath of the needle cannula when the inner member is in the secondposition.
 12. The safety catheter of claim 1, the inner member includingat least one projection for limiting movement of the needle cannula whenthe inner member is in the second position.
 13. The safety catheter ofclaim 1, the distal tip being sharp.
 14. The safety catheter of claim 1,the outer member being a thin-walled metal tubular member.
 15. Thesafety catheter of claim 1, the arms of the inner member defining atapered bore having a cross dimension smaller than a cross dimension ofthe needle cannula so as to block the path of the needle cannula whenthe inner member is in the second position.
 16. The safety catheter ofclaim 1, wherein the catheter hub includes at least one wing.
 17. Thesafety catheter of claim 1, wherein the catheter hub includes a sideport.
 18. The safety catheter of claim 1, the inner member configured tobe axially slidable between the first position and an intermediateposition, wherein in the intermediate position the distal tip is withinthe inner member and the free ends of the arms are brought into closeproximity such that the distal tip is shielded.
 19. The safety catheterof claim 18, the inner member being entirely received within the outermember in the intermediate position thereof.
 20. The safety catheter ofclaim 18, the distal tip being within the outer member in theintermediate position.